Diane 35 is used for the treatment of androgen-dependent diseases in women, such as pronounced form of acne, especialy those which are accompanied by seborrhea or by inflamation or formation of nodes, androgenetic alopecia and mild forms of hirsutism and it is also combined oral contraceptive to prevent pregnancy. Each of 21 tablets contains two different female hormones, which are cyproterone acetate (2 mg) and enthinyl estradiol (0.035 mg).
Indications: oral contraceptive, acne treatment preparations
Side effects: dizzines, headache, mental depression, nausea, abdominal pain, breast pain, breast tenderness, increase in body weight. Less common side effects are migraine, rash, melasma. Rare side affects are arterial thromboembolism, cerebral haemorrage, cerebral thrombosis, coronary thrombosis, gall bladder disease, hepatic adenomas, hypertension, contact lens intolerance, thrombosis, breast secretion, vaginal secretion, decrease in body weight. If you notice any side effects not mentioned in this leaflet, please inform your doctor.
Contraindications: you should not use Diane 35 if you have any of the following conditions:
- thromboplebitis, thromboembolic disorders, history of deep-vein thrombophlebitis, cerebral vascualr disease, MI, coronary artery disease
- known or suspected breast carcinoma or estrogen-dependent neoplasia, carcinoma of endometrium
- hepatic adenomas / carcinomas
- undiagnosed abnormal genital bleeding
- known or suspected pregnancy
- cholestatic jaundice of pregnancy / jaundice with prior pill use
- hypersensitivity to any component of the product
- acute liver disease
- uncontrolled hypertension
- diabetes mellitus with vascular complications
If anything on the above list applies to you, tell your doctor before starting to use Diane 35.
Important information: you may need to be kept under close observation if:
- you smoke
- you have diabetes
- you are overweight
- you have a high blood pressure
- you have a heart valve disorder or a certain heart rythm disorder
- you or someone in your close family has had a thrombosis, a heart attack or a stroke
- you suffer from migraine
- you suffer from epilepsy
- you or someone in your close family have or have had high cholesterol or triglycerides
- you or someone in your close family have or have had a breast cancer
- you have a liver or gallbladder disease
- you have an operation, or if your ability to move around is limited for a long period of time
If any of above conditions appear for the first time, come back or get worse while using the Diane 35, you should contact your doctor.
Use and dosage: tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Start with the number 1 tablet in the top corner. Follow the direction of the arrows untill all 21 tablets have been taken. Then no tablets for 7 days = each subsequent pack is started 7 days after the last tablet of the current pack. During these tablet-free interval of 7 days a withdrawal bleeding usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.
Missed dose: if you miss a dose of Diane 35 tablets, take it as soon as you remember, even if this means taking two tablets at the same time. Then continue the tablets as usual. If tablet is missed in the week 3, the next pack must be started as soon as the active tablets in the current pack are finished.
Package Contents: 1 calendar pack of 21 tablets with female hormones cyproterone acetate and enthinyl estradiol each – total 21 tablets in one box.
Active ingredient: cyproterone acetate 2 mg and enthinyl estradiol 0.035 mg (21 tablets)
Manufacturer: Bayer Schering do Brasil Quimica e Farmaceutica Ltda, Sao Paolo, Brazil
Storage: keep Diane 35 in its calender blister until used. Store at room temperature below 30°C, keep away from direct sunlight and do not refrigerate.